Financial Data and Key Metrics Changes - Revenues for fiscal year 2022 increased to $1.4 million from $1.0 million in fiscal year 2021, primarily due to increased revenue from collaborative partners [23] - Total operating expenses decreased by approximately $300,000 year over year, totaling $13.3 million in 2022 compared to $13.6 million in 2021 [24] - Net loss in 2022 was $11.9 million compared to a net loss of $12.6 million in 2021, with cash used in operations totaling $10.6 million in both years [25] Business Line Data and Key Metrics Changes - The CardiAMP cell therapy platform is being advanced in two cardiac clinical indications, with significant patient enrollment and positive clinical data reported [9][10] - The allogeneic mesenchymal stem cell program for ischemic heart failure (BCDA-03) is designed for patients ineligible for the autologous therapy, with clinical grade cells ready for use [17][18] - The allogeneic mesenchymal stem cell program for acute respiratory distress syndrome (BCDA-04) is expected to commence following the initiation of BCDA-03 [19] Market Data and Key Metrics Changes - The reachable US market for the CardiAMP cell therapy programs is estimated at 1.6 million patients [9] - The company anticipates significant licensing and royalty revenues from its therapies if proven effective and commercialized [23] Company Strategy and Development Direction - The company is focused on advancing two cell therapy platforms targeting unmet cardiovascular and pulmonary diseases [6] - BioCardia aims to partner its CardiAMP cell therapy platform internationally and license its Neurokinin-1 Receptor Positive mesenchymal stem cells for other clinical indications [20] - The company is also looking to monetize its Avance transseptal introducer sheath product, which has seen significant acquisition interest in the market [21] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing need for new therapeutic solutions in heart failure, with current treatments showing limited impact on mortality [7] - The company is optimistic about the upcoming discussions with the FDA regarding the adaptive statistical analysis plan, which could enhance the trial's design and outcomes [35][52] - Management emphasized the importance of maximizing the probability of technical success while ensuring near-term commercial viability [36] Other Important Information - The company has received breakthrough device designation from the FDA for its CardiAMP cell therapy in ischemic heart failure [36] - The next pre-specified formal data safety monitoring board review is anticipated in the second quarter of 2023 [12] Q&A Session Summary Question: Can you provide perspective on the blinded echo data for the rolling cohort? - Management explained that the patient population included those with a left ventricular ejection fraction of 20% to 40%, and the results showed a 35% improvement in ejection fraction with 100% survival at two-year follow-up [28][29] Question: What are the immediate needs regarding manufacturing capacity? - Management stated that current manufacturing capabilities are sufficient for all ongoing clinical trials, with room for expansion if needed [30][32] Question: What are the expectations for the upcoming FDA call? - Management indicated that they expect clarity on the adaptive statistical analysis plan and emphasized the importance of patient safety data in trial design [51][52] Question: What is the status of the BCDA-02 trial? - Management confirmed that the rolling cohort is up to 10 patients, and they are working to streamline the trial design for faster enrollment [53][54] Question: How does the company plan to enhance enrollment across its trials? - Management noted that patients excluded from the CardiAMP trial could qualify for the chronic myocardial ischemia trial, providing multiple opportunities for patient inclusion [55]
BioCardia(BCDA) - 2022 Q4 - Earnings Call Transcript